Home Blood Pressure Intervention in the Community Trial
Shanghai Institute of Hypertension
10,000 participants
May 6, 2023
INTERVENTIONAL
Conditions
Summary
The primary purpose of the study is to explore whether a lower home blood pressure target (125/75 v.s. 135/85 mmHg) would be beneficial to elderly treated hypertensive patients in terms of reduced incidence of cardiovascular events. The study also aims to promote the application of standardised and information-based home blood pressure monitoring in community hypertension management.
Eligibility
Inclusion Criteria4
- Aged 60-80 years old
- Have been taking antihypertensive drugs for more than 2 weeks
- The average SBP and/or DBP of 7-day home blood pressure monitoring ≥135/85 mmHg
- Willing to participate, adhere to follow-up, and sign the written informed consent form
Exclusion Criteria10
- Arm circumference too large or too small (less than 18 cm or greater than 42 cm) to fit the cuff in case of inaccurate measurement
- Invalid home blood pressure monitoring. The valid home blood pressure monitoring requires consecutive measurements for at least 3 days, with not less than 1 measurement in the morning and evening, respectively.
- Office blood pressure indicates stage 3 clinic hypertension (≥180/110 mmHg) during the screening period
- Suspected or known secondary hypertension
- Orthostatic hypotension, defined as a decrease in systolic blood pressure greater than 20 mmHg or diastolic blood pressure greater than 10 mmHg within 3 minutes when position is changed from sitting to standing
- eGFR<30 ml/min/1.73m2 or end-stage renal disease
- Cardiovascular events occured within the past 3 months, such as myocardial infarction, stroke, acute heart failure, hospitalization for unstable angina, undergoing coronary artery revascularization or bypass grafting
- Abnormal liver function (ALT/AST/total bilirubin more than 2 times the upper limit of normal value)
- Severe somatic disease with a life expectancy of less than 3 years, or diagnosed with cancer within the past 2 years requiring treatment
- Doctors deem that the participation would do harm to the patients or the patients would have poor compliance.
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Interventions
If the target home BP level is not achieved during the follow-up periods, type and dosage of antihypertensive drugs will be adjusted according to current guidelines and physician's clinical experience.
If the target home BP level is not achieved during the follow-up periods, type and dosage of antihypertensive drugs will be adjusted according to current guidelines and physician's clinical experience.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05858944